Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC POWERED, ADJUSTABLE HOSPITAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC POWERED, ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number UNK_MED
Device Problem No Audible Alarm (1019)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/14/2021
Event Type  Injury  
Event Description
It was reported that a patient got out of an s3 bed.The bed exit was set and alarmed and the staff heard the alarm but because the bed was not connected to the nurse call system the staff could not identify where the alarm was coming from (clinician not aware of possible patient fall condition).It was reported that the patient broke their legs as a result of the fall.
 
Event Description
It was reported that a patient got out of an s3 bed.The bed exit was set and alarmed and the staff heard the alarm but because the bed was not connected to the nurse call system the staff could not identify where the alarm was coming from (clinician not aware of possible patient fall condition).It was reported that the patient broke their legs as a result of the fall.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
BED, AC POWERED, ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key12192521
MDR Text Key262410172
Report Number0001831750-2021-00992
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/21/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received06/21/2021
Supplement Dates FDA Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-